AIDS vaccine trials: a moral and ethical challenge

Testing the AIDS vaccine will be ethically challenging for researchers

June 29, 1998
Web posted at: 8:11 p.m. EDT (0011 GMT)

(CNN) -- This summer, San Francisco-based researchers launch the first global
AIDS vaccine trials -- a medical step forward which is nonetheless rich in
moral dilemmas. It's one of the most promising developments in the war on AIDS, and one
of the most ethically challenging, as researchers seek uninfected but
vulnerable participants.

Vaxgen Inc. has devised a three-year study in which participants
will be counseled around 15 times.

"In the U.S., it'll be over 5,000 men who have sex with men and women who
have sex partners who are HIV positive," says Vaxgen's Dan Reiner.

One out of every three will get a placebo. In trials among 2,500 needle users
in Thailand, placebo and vaccine will be divided evenly.

Trials of this nature raise the risk of false security among
participants, according to Dr. Lawrence Gostin, a professor of law and public health
at Georgetown University.

"The ethical thing to do is to tell both the placebo controlled group
and the experimental group that they should avoid having unprotected sex. They
should avoid sharing needles when they use drugs," Gostin says.

As part of the study, each time participants receive counseling
they will be reminded that they could be getting a placebo and
cautioned against needle-sharing and unprotected sex.

No risk of AIDS infection from vaccine

The vaccine itself poses no risk of infecting participants, but there
are other moral and social challenges facing trial participants-
issues of privacy and confidentiality.

"If you're participating in an HIV vaccine trial, in itself, you've
got a privacy problem, people will assume you to be at risk," says Dr. Gostin.
"They might think you're a homosexual or a user of drugs."

Another area of concern for participants is discrimination. If the vaccine
makes a person test positive for AIDS, even though they
don't have the virus, they could face discrimination in areas ranging from jobs
to health insurance.

Researchers are also taking steps to ensure that participants from third
world countries will have access to any vaccine that is approved.

"We've already been talking with the World Health Organization,
U.S. banks, the World Bank and other organizations like U.N. AIDS to work
with them when
the vaccine is proven effective, to be able to get it to them."

Vaccine trials in the United States will take place in Chicago, Denver, Los Angeles,
Philadelphia and St. Louis.